LV15082B - Cream for restoring epidermal lipid barrier of the facial skin, neck and decollette area in metabolic syndrome patients - Google Patents
Cream for restoring epidermal lipid barrier of the facial skin, neck and decollette area in metabolic syndrome patients Download PDFInfo
- Publication number
- LV15082B LV15082B LVP-15-90A LV150090A LV15082B LV 15082 B LV15082 B LV 15082B LV 150090 A LV150090 A LV 150090A LV 15082 B LV15082 B LV 15082B
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- Latvia
- Prior art keywords
- skin
- cream
- metabolic syndrome
- patients
- neck
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Abstract
Description
IZGUDROJUMA APRAKSTSDESCRIPTION OF THE INVENTION
Izgudrojums attiecas uz medicīnu, ir saistīts ar ģimenes medicīnu (ģimenes ārstu praksi), terapiju, endokrinoloģiju, gerontoloģiju, dermatoloģiju un kosmetoloģiju, kā arī risina sejas ādas, kakla un dekoltē zonas epidermālās lipīdu barjeras atjaunošanas problēmas pacientiem ar metabolisko sindromu.The invention relates to medicine, relates to family medicine (family doctors' practice), therapy, endocrinology, gerontology, dermatology and cosmetology, and solves the problems of restoring the epidermal lipid barrier of the facial skin, neck and décolleté in patients with metabolic syndrome.
TEHNIKAS LĪMENISTECHNICAL LEVEL
Metaboliskais sindroms (MS) - izmaiņu komplekss, kas saistīts ar vielmaiņas traucējumiem, kura gadījumā attīstās nejutība pret insulīnu, tiek traucēta glikozes uzņemšana šūnās. Metaboliskajam sindromam seko dažādu saslimšanu komplekss: hipertonija, aptaukošanās, sirds išēmiskā slimība, 2. tipa cukura diabēts. Metaboliskā sindroma attīstību raksturo vidukļa apkārtmēra palielināšanās: vīriešiem - vairāk par 102 cm, sievietēm - vairāk par 88 cm. Arteriālā asinsspiediena līmenis 135/85 mmHg. Asinīs kostatē augstu lipīdu peroksidācijas produktu saturu. Oksidanti sāk aktivēt šūnu reakcijas, kas sagrauj olbaltumvielas, lipīdus, DNS. Tiek traucēta ādas barjerfunkcija un tā intensīvāk zaudē mitrumu, kļūst sausa, kas izraisa pārmērīgu ādas zvīņošanos, ādas ragveida slāņa sabiezējumu, piešķir ādai pelēcīgu nokrāsu, sekmē dažādu ādas saslimšanu attīstību: seboreja, atrofiskais dermatīts, psoriāze, ekzēma u.c. saslimšanas [ 1 ].Metabolic syndrome (MS), a complex of changes associated with metabolic disturbances in which insulin sensitivity is impaired and cellular glucose uptake is impaired. Metabolic syndrome is followed by a complex of diseases: hypertension, obesity, ischemic heart disease, type 2 diabetes. The development of the metabolic syndrome is characterized by an increase in waist circumference: more than 102 cm for men and 88 cm for women. Arterial blood pressure level 135/85 mmHg. High levels of lipid peroxidation products are stored in the blood. Oxidants begin to activate cellular reactions that destroy proteins, lipids, DNA. The barrier function of the skin is impaired and intensively loses moisture, becomes dry, causing excessive flaking, thickening of the horny layer of the skin, giving the skin a gray tint, and promoting the development of various skin conditions: seborrhea, atrophic dermatitis, psoriasis, eczema, etc. diseases [1].
Cilvēka ķermeņa āda ir sarežģīta bioloģiska audu sistēma, kuru veido epiderma, denna un zemādas tauku šūnaūdi. Epidermas bazālajā slānī atrodas melanocīti un Langerhansa šūnas, kas izvietotas uz bazālās membrānas. Epidermas pamatslānī atrodas protoplazmas šķiedras, granulveida slāni . veido šūnas ar keratohialīna kompleksiem. Denna - ādas savienojošā daļa, galvenais ādas apjoms. Derma ar bazālo membrānu norobežota no epidermas [2],Human body skin is a complex biological tissue system made up of epidermis, denna and subcutaneous fat cells. The basal layer of the epidermis contains melanocytes and Langerhans cells located on the basement membrane. The basal layer of the epidermis contains a protoplasmic, granular layer. forms cells with keratohialin complexes. Denna - the connecting part of the skin, the main volume of the skin. Dermis with basal membrane isolated from epidermis [2],
Epidermas ārējo daļu klāj raga slānis, uz kura izveidota ūdens-lipīdu mantija ar vāji skābu vidi - skābuma līmenis 4,5-5,5 pH. Šāds skābuma līmenis rada baktericīdu iedarbību un sekmē lipīdu sintēzi. Ādas skābes īpašības saistītas ar sviedriem un ādas taukiem. Daudzie uz ādas nokļūstošie mikrobi iet bojā 20-30 minūšu laikā [3], Ūdens-lipīdu mantija veido epidermālo barjeru, kas sastāv no ragveida šūnām - zvīņām, kuras tiek sauktas par - komeocītiem, starp kuriem izvietoti epidermālie starpšūnu lipīdi - keramīdi. Keramīdi savieno komeocītus necaurejamā, viengabalainā epidermālā barjerā. Keramīdu molekulām ir polāra struktūra, jo tām ir hidrofilas galvas (dod priekšroku ūdenim) un lipofilas astes (dod priekšroku taukiem). Epidermālā lipīdu barjera neļauj iekļūt ādā kaitīgām vielām, iesaistās dermas ūdens hemostāzes regulēšanā. Lipīdu barjera sastāv no holesterīna, keramīdiem, nepiesātinātām taukskābēm (Omega-3, Omega-6). Nepiesātinātajām taukskābēm Omega-3, Omega-6 piemīt pretiekaisuma iedarbība, tās stimulē Langerhansa šūnas un nostiprina epidermālo lipīdu barjeru [4]. Brīvās taukskābes izvietotas lipīdu slānī, apkārt keramīdiem, tās sekmē ādas ūdens necaurlaidības funkciju, veido ūdens-eļļas emulsiju. Ja lipīdu barjera tiek traucēta, tad ādā iekļūst mikroorganismi, ķīmiskie un citi eksogēnie agresīvie faktori.The outer part of the epidermis is covered by a stratum corneum, on which a water-lipid mantle with a slightly acidic environment is created, with an acidity of 4.5 to 5.5 pH. This level of acidity produces bactericidal effects and promotes lipid synthesis. The acid properties of the skin are associated with perspiration and skin fat. Many microbes that penetrate the skin die within 20-30 minutes [3], and the water-lipid mantle forms an epidermal barrier made up of horny cells called scales called "comaocytes", between which epidermal intercellular lipids, ceramides, are located. Ceramides bind comaocytes in an impermeable, integral epidermal barrier. Ceramide molecules have a polar structure because they have hydrophilic heads (preferable to water) and lipophilic tails (preferable to fat). The epidermal lipid barrier prevents the entry of harmful substances into the skin, and regulates the hemostasis of the dermis water. The lipid barrier consists of cholesterol, ceramides, unsaturated fatty acids (Omega-3, Omega-6). Unsaturated fatty acids Omega-3, Omega-6 have anti-inflammatory properties, stimulate Langerhans cells and strengthen the epidermal lipid barrier [4]. The free fatty acids are located in the lipid layer, around the ceramides, they promote the water-impermeable function of the skin and form a water-in-oil emulsion. If the lipid barrier is disturbed, microorganisms, chemical and other exogenous aggressive factors enter the skin.
Ādai ir imūno šūnu sistēma, galvenā loma ir Langerhansa šūnām (2-5 % šūnu epidermas). Langerhansa šūnas piedalās baktēriju iznīcināšanā un ierosina imūno atbildi, kurā piedalās dermālās dendrītu šūnas, epidermālie makrofagi u.c. Ādas novecošanās saistīta ar imūnās sistēmas stāvokli [5]. Pēc 25 gadu vecuma organismā sāk darboties dabiskas novecošanās mehānisms: samazinās ādas makrofagu daudzums, oksidanti sāk aktivēt šūnu reakcijas, radot olbaltumvielu, lipīdu un DNS traucējumus. īpaši aktīvi ādas paātrinātas, patoloģiskas novecošanās process sākas slimniekiem ar metabolisko sindromu (MS). · Zināms, · ka metabolisko sindromu pavada latents iekaisums, kas izraisa peroksidācijas procesu aktivizāciju. Lipīdu peroksidācijas produktu uzkrāšanās, lipoproteīnu un lipīdu slāņa lipīdu oksidatīvie bojājumi izpaužas kā ādas struktūras komponentu morfoloģiskās izmaiņas [6]. Aizsardzības sistēma, ko veido antioksidanti, pacientiem ar metabolisko sindromu ir novājināta · un/vai neefektīvā. Metaboliskā sindroma gadījumā rodas oksidatīvais stress: tiek traucēta keratinocītu veidošanās, novērojams transepidermālā ūdens pastiprināts zudums, · ādas sausums, plaisas un erozijas. Izmaiņas · izraisa ādas mikrofloras disbalansu un sēnīšu skaita pieaugumu, papilomu · rašanos. Ādas epidermālās lipīdu barjeras atjaunošana pacientiem ar metabolisko sindromu ir īpaši aktuāls uzdevums [7].The skin has an immune cell system, with Langerhans cells (2-5% of cells in the epidermis) playing a key role. Langerhans cells are involved in killing bacteria and initiate an immune response involving dermal dendritic cells, epidermal macrophages, and so on. Skin aging is linked to the condition of the immune system [5]. After the age of 25, the body starts a natural aging mechanism: the amount of skin macrophages decreases, oxidants begin to activate cellular responses, causing protein, lipid and DNA damage. the process of accelerated, abnormal skin aging is particularly active in patients with metabolic syndrome (MS). · It is known · that the metabolic syndrome is accompanied by latent inflammation leading to the activation of peroxidation processes. The accumulation of lipid peroxidation products, and lipid oxidative damage of lipoproteins and lipid layer, is manifested as morphological changes in the components of the skin structure [6]. The defense system formed by antioxidants is weakened and / or ineffective in patients with metabolic syndrome. Metabolic syndrome causes oxidative stress: disruption of keratinocyte formation, increased loss of transepidermal water, dry skin, cracks and erosion. Changes · cause an imbalance of the microflora of the skin and an increase in the number of fungi, papillomas. Restoration of the skin epidermal lipid barrier in patients with metabolic syndrome is a particularly urgent task [7].
1. tabula - ādas · epidermālās lipīdu barjeras traucējumu analīze un to noteikšanas metodes. .Table 1 - Analysis of skin · epidermal lipid barrier disorders and methods for their detection. .
1. tabulaTable 1
Ādas epidermālās lipīdu barjeras traucējumu analīzi veic ar dermatoskopijas starpniecību (ādas pH, mitruma/sausuma, taukainības novērtēšana) un siaskopijas starpniecību (dispigmentācijas izvērtējums un mikroreljefa izpēte). Transepidermālā ūdens zuduma mērīšanai izmanto sensoru Tewameter® TM 300, Courage + Khazaka electronic GmbH,· Vācija. Siaskopijas · veikšanai izmanto siaskopu MoleViesv SIAscope V·' Handset, Astron, Lielbritānija. Dermatoskopijas veikšanai izmanto dermatoskopu HEINE alpha + Heine Optotechnic, Vācija. Tos izmantojot, analizē uz datoru pārsūtītos rādītājus, vienlaikus veicot vairāku epidermālās lipīdu barjeras stāvokļa atspoguļojošo raksturlielu analīzi [8-11]:Analysis of skin epidermal lipid barrier disorders is performed through dermatoscopy (assessment of skin pH, moisture / dryness, oilyness) and siascopy (assessment of dispigmentation and microrelief study). Tewameter® TM 300, Courage + Khazaka electronic GmbH, Germany, is used to measure transepidermal water loss. MiasViesv SIAscope V · 'Handset, Astron, United Kingdom is used to carry out the siascope. HEINE alpha + Heine Optotechnic, Germany, is used for dermatoscopy. By using them, the parameters transmitted to the computer are analyzed, while several characteristics reflecting the state of the epidermal lipid barrier are analyzed [8-11]:
• Korneometrija (ādas mitrums, ūdens saturs epidermas raga slānī), izmanto ar dermatoskopa palīdzību. Komeometrijas princips pamatojas uz dielektriskās vides elektriskās kapacitātes mērīšanu. Jebkādas dielektriskās konstantes izmaiņas, kas saistītas ar ūdens satura svārstībām ādas virsējos slāņos, izraisa mērīšanas sistēmas kapacitatīvo raksturlielumu izmaiņas. Mitrināšanu vērtē pēc skalas. Par pamatu tiek ņemta ūdens dielektriskā kapacitāte - 81, izšķir 4-6 ādas mitrinājuma pakāpes (ļoti augsta mitrinājuma pakāpe - 45,0-99,9; augsta, normāla 4• Corneometry (moisture of the skin, water content in the stratum corneum of the epidermis), used with the help of a dermatoscope. The principle of comometry is based on the measurement of the electrical capacity of the dielectric medium. Any change in the dielectric constant associated with fluctuations in the water content of the skin's upper layers causes a change in the capacitance characteristics of the measuring system. Wetting is evaluated on a scale. The basis is the dielectric capacity of the water - 81, distinguishes 4-6 degrees of skin moisture (very high degree of humidity - 45.0-99.9; high, normal 4
35,1 -40,0; pazemināta, zema -20,1-29,9; atūdeņota - zemāka par 20,0).35.1 -40.0; depressed, low -20.1 to 29.9; dehydrated - below 20.0).
• Transepidermālā ūdens zuduma mērīšana, mērījums ūdens iztvaikošanai no ādas virsmas, kas pamatojas uz difūzijas principu atvērtā kamerā. Metode pamatojas uz ūdens parciālā spiediena mērīšanu slēgtā kamerā ar vienu mitruma sensoru. Noteiktā laika periodā mēra parciālā spiediena pieaugumu kamerā.• Measurement of transepidermal water loss, a measurement of water evaporation from the skin surface based on the principle of diffusion in an open chamber. The method is based on measuring the partial pressure of water in a closed chamber with a single humidity sensor. The increase in partial pressure in the chamber over a period of time is measured.
• Skābes-bāzes līdzsvars, pH-metrija. pH-metrijas sensorā izmanto ļoti precīzu stikla elektrodu.• Acid-base balance, pH-metry. The pH meter uses a very precise glass electrode.
• Sebumetrija, sebumetrijas metodi izmanto, lai dažādās zonās noteiktu ādas taukainību. Metodes pamatā fotometrijas princips. Lieto polimēra plēvi, kura ir selektīvs lipīdu absorbents, kuru pirms un pēc raidītāja aplikācijas uz ādas virsmas ievieto fotometrā. Mērīšanas rezultāti tiek izteikti mkg/cm. Sebumetrijas rādītāji nav atkarīgi no ādas mitruma. Taukainības sensors (sponžs) sastāv no trijiem komponentiem, viens no tiem ir papīrs - matēts, jutigs pret tauku sastāvdaļām, kurš reaģē tikai uz sebumu (ādas taukiem), absorbē to, mikroprocesors apstrādā iegūtās krāsas izmaiņas, nosakot ādas tipu: sausa, normāla, taukaina vai kombinēta.• Sebummetry, a sebummetric technique used to determine the oily nature of different areas. The method is based on the principle of photometry. A polymer film is used, which is a selective lipid absorber, which is placed on the skin surface of the photometer before and after application of the transmitter. Measurement results are expressed in mcg / cm. Sebummetry scores are independent of skin moisture. The grease sensor (bronze) consists of three components, one of which is paper - matte, sensitive to fat components, which reacts only to sebum (skin fat), absorbs it, the microprocessor processes the resulting discoloration to determine skin type: dry, normal, oily or combined.
• Meksametrija (dažādu ādas pigmentu satura novērtējums), ļauj izmērīt melatonīna pigmenta daudzumu ādā un eritēmas pakāpi. Mērīšanas princips pamatots uz to, ka āda dažādās spektra zonās uzsūc dažāda garuma gaismas viļņus. Meksametrijas metode ir īpaši lietderīga, veicot ultravioletā bojājuma izraisītu alerģijas vai iekaisuma reakcijas skaitlisko izvērtēšanu.• Mexometry (an estimate of the content of various skin pigments), allows you to measure the amount of melatonin pigment in the skin and the degree of erythema. The principle of measurement is based on the fact that the skin absorbs light waves of different lengths in different areas of the spectrum. The Mexometric method is particularly useful for the numerical evaluation of an allergy or inflammatory response to ultraviolet damage.
• Mikroreljefa izpēte ar mikrofotografēšanu - mūsdienīgas ciparu aparatūras izmantošana ādas virsmas reljefa un mikrostruktūras izvērtēšanai (krunkainība, gludums, raupjums) ar sekojošu attēlu saglabāšanu un iespēju salīdzināt, kā arī analizēt mērījumus ārstēšanas kursa laikā. Ādas lobīšanās galvenokārt atkarīga no epidermas proliferācijas ātruma, kā arī no ūdems līdzsvara. Normai atbilstoši aizejošie komeocīti ir apmēram vienāda, neliela izmēra. Apjomīgais lielo šūnu skaits liecina par ādas bojājumu un dehidratizāciju.• Micro relief research with micro photography - use of modern digital equipment for evaluation of skin surface relief and microstructure (wrinkle, smoothness, roughness) with subsequent preservation of images and possibility to compare and analyze measurements during treatment course. The exfoliation of the skin depends mainly on the rate of epidermal proliferation as well as on the water balance. Normally, the outgoing comocytes are about the same, small size. The large numbers of large cells indicate skin damage and dehydration.
Zināmas kosmētiskas kompozīcijas ādas sausuma profilaksei un ārstēšanai ultravioleto (UV) bojājumu gadījumā. Zināmās kompozīcijas satur augu ekstraktus un komponentus kombinācijā ar dažādām eļļām [12-14]. Zināms, ka UV prooksidatīvo iedarbību iespējams koriģēt ar vitamīniem-antioksidantiem [15-21]. Zināma retinoīdu lietošana UV bojājumu novēršanai [22]. Zināms krēms ar selēnmetionīnu vietējai lietošanai insolācijas laikā, lai aizsargātos no ādas vēža [23]. Zināma mitrinošu krēmu lietošana, kuros ir liels keramīdu pārsvars, kuri paredzēti lietošanai bērniem ar atopisko dermatītu [24],Known cosmetic compositions for the prevention and treatment of dry skin in the case of ultraviolet (UV) damage. Known compositions contain plant extracts and components in combination with various oils [12-14]. It is known that the pro-oxidative effect of UV can be corrected by vitamin-antioxidants [15-21]. Known use of retinoids to prevent UV damage [22]. A topical cream with selenomethionine for topical application during insolation to protect against skin cancer is known [23]. Known use of high-ceramic moisturizing creams for use in children with atopic dermatitis [24],
Zināma mitrinošu līdzekļu lietošana sausas ādas ārstēšanai [25-26]. Zināma krēmu lietošana, kuros tokoferols ir kā antioksidants aizsardzībai no ādas UV bojājuma [27].Known use of moisturizers for dry skin treatment [25-26]. The use of creams containing tocopherol as an antioxidant for protection against UV damage of the skin is known [27].
Zināmie mitrinošie un mīkstinošie līdzekļi, kuri atvieglo ādas sausuma simptomus, ādu uzlabo mitrinot, bet neatjauno, kā arī neatrisina epidermālās lipīdu barjeras atjaunošanas problēmu pacientiem ar metabolisko sindromu.Known moisturizers and emollients, which alleviate the symptoms of dry skin, improve skin hydration but do not restore it, nor do they solve the problem of restoring the epidermal lipid barrier in patients with metabolic syndrome.
Zināms vazelīns [28], kas tiek lietots, lai īslaicīgi aizstātu bojāto ādas barjeru. Vazelīns un līdzekļi, kas bāzējas uz to, tiek izmantoti pēc medicīniskām un kosmētiskām procedūrām, kurās notiek raga slāņa noņemšana, tādām kā ādas slīpēšana ar lāzeru, dermabrāzija (mehāniska epidermas noņemšana), pīlings. Vazelīna trūkums ir slikta uzsūkšanās ādā, jo āda tiek pārklāta ar taukainu slāni, kas sarežģī tā lietošanu. Vazelīnam piemīt spēcīgs okluzīvs efekts (mitruma izgarošanas bloķēšana), kas noved pie ādas caurlaidības traucējumiem un blaknēm. Vazelīnu rekomendē lietot tikai akūta epidermālās barjeras bojājuma gadījumā, kad nepieciešams novērst īpaši aktīvu ādas šūnu reakciju, kuras pēkšņi zaudējušas ārējo aizsardzību, kā ari tajās situācijās, kad āda pati nav spējīga formēt pilnvērtīgu barjeru. Pārējos gadījumos bloķēt ūdens iztvaikošanu caur bojāto raga slāni nerekomendē.Known petroleum jelly [28] which is used to temporarily replace a damaged skin barrier. Petroleum jelly and preparations based thereon are used after medical and cosmetic procedures involving removal of the stratum corneum, such as laser skin polishing, dermabrasion (mechanical removal of the epidermis), peeling. Vaseline deficiency is poor absorption in the skin, because the skin is covered with a greasy layer, which complicates its use. Vaseline has a strong occlusal effect (blocking moisture vapor), leading to skin permeability disorders and side effects. Vaseline is recommended for use only in cases of acute damage to the epidermal barrier, where it is necessary to prevent a particularly active skin cell reaction that has suddenly lost its external protection, and in situations where the skin itself is unable to form a complete barrier. In other cases blocking the evaporation of water through the damaged stratum corneum is not recommended.
Zināma tauku emulsija, ar kuru vienlaikus iespējama ādas mitrināšana un barošana [29]. Zināmā tauku emulsija neveic aizsargājošu iedarbību pret ādas novecošanās procesiem, kurus izraisījuši ādas brīvo radikāļu bojājumi pacientiem ar metabolisko sindromu.A known fat emulsion that can simultaneously moisturize and nourish the skin [29]. The known fat emulsion does not have a protective effect against skin aging processes caused by damage to free radicals of the skin in patients with metabolic syndrome.
Zināms krēms ar selēnu un E vitamīnu [30], kas ir augsti dispersa rafinētas ūdeles eļļas emulsija ūdenī stabilizēta ar emulsijas vaskiem. Krēms nenovērš lipīdu barjeras atjaunošanu pacientiem ar metabolisko sindromu. Turklāt, ilgstoši lietojot krēmu ar augstu ūdens saturu, palēninās raga slāņa atjaunošanās, kas nelabvēlīgi ietekmē ādu pacientiem ar metabolisko sindromu [31]. Zināmas dažādas kompozīcijas no augu ekstraktiem ādas barjerās funkcijas stāvokļa uzlabošanai [32-36]. Zināmās kompozīcijas neatjauno lipīdo slāni pacientiem ar metabolisko sindromu.Known cream with selenium and vitamin E [30], a highly dispersed refined mink oil emulsion in water stabilized with wax emulsion. The cream does not prevent the restoration of the lipid barrier in patients with metabolic syndrome. In addition, prolonged use of a high water content cream slows down the regeneration of the stratum corneum, which adversely affects the skin of patients with metabolic syndrome [31]. Various compositions of plant extracts for improving the barrier function of the skin are known [32-36]. Known compositions do not restore the lipid layer in patients with metabolic syndrome.
Nav zināms līdzeklis epidermālās lipīdu barjeras atjaunošanai pacientiem ar metabolisko sindromu.There is no known means to restore the epidermal lipid barrier in patients with metabolic syndrome.
IZGUDROJUMA IZKLĀSTSSUMMARY OF THE INVENTION
Izgudrojuma mērķis un tehniskais rczulāts: izstrādāt krēma sastāvu sejas ādas, kakla un dekoltē zonas epidermālās lipīdu barjeras atjaunošanai pacientiem ar metabolisko sindromu, kas novērstu brīvo radikāļu radīto bojājumu lipīdu slānim, kuru izraisījis latents iekaisums, piemītošs metaboliskajam sindromam, un atjaunotu lipīdu slāni:AIM AND TECHNICAL PROCESS OF THE INVENTION: To develop a cream composition for restoring the epidermal lipid barrier of the facial skin, neck and décolleté in patients with metabolic syndrome to prevent free radical damage to the lipid layer caused by latent inflammation inherent in metabolic syndrome:
• jaunā sastāva komponentu un to sastarpējās attiecības meklēšana, • krēma izgatavošanas tehnoloģijas izstrādāšana, • krēma optimālās formas izstrādāšana.• search for new formulation components and their relationship, • development of cream manufacturing technology, • development of optimal cream form.
Izvirzīto mērķi sasniedz tādējādi, ka krēms satur selēn-L-metionīnu, α-tokoferola acetātu, skvalānu, metil-4- hidroksibenzoātu, glicerīna monostearātu 60, cetilspirtu, vidēji garo ķēžu triglicerīdus, balto vazelīnu, makrogola-20-glicerīna monostearātu, 1,2-propāndiolu un attīrītu ūdeni. Pie tam krēms satur selēn-Lmetionīnu, α-tokoferola acetātu, skvalānu, metil-4-hidroksibenzoātu, glicerīna monostearātu 60, cetilspirtu, vidēji garo ķēžu triglicerīdus, balto vazelīnu, makrogola20-glicerina monostearātu, 1,2-propāndiolu un attīrītu ūdeni šādās komponentu masas attiecībās g (%):The object of the present invention is that the cream comprises selenium L-methionine, α-tocopherol acetate, squalane, methyl 4-hydroxybenzoate, glycerol monostearate 60, cetyl alcohol, medium chain triglycerides, white petroleum jelly, macrogol-20-glycerol monostearate, 1, 2-propanediol and purified water. Additionally, the cream contains selenium-Lmethionine, α-tocopherol acetate, squalane, methyl 4-hydroxybenzoate, glycerol monostearate 60, cetyl alcohol, medium chain triglycerides, white petroleum jelly, macrogol20-glycerol monostearate, 1,2-propanediol and purified water. mass ratio g (%):
nokrāsu, vāji izteiktu un patīkamu aromātu, atbilstošu lietotajai tauku bāzei. Visi krēma komponenti atļauti lietošanai par farmaceitiskiem līdzekļiem.a slight, mild and pleasant aroma, appropriate to the fat base used. All components of the cream are authorized for pharmaceutical use.
Krēms paredzēts sejas ādas, kakla un dekoltē zonas epidermālās lipīdu barjeras atjaunošanai pacientiem ar metabolisko sindromu.The cream is intended for restoring the epidermal lipid barrier of the facial skin, neck and décolleté in patients with metabolic syndrome.
Krēma sastāvs satur šādus komponentus:The cream contains the following components:
Selēn-L-metionīns (Selenomethionine, Se-Met (SEM)) - selēnmetionīna L-enantiomērs, dabīga selēnu saturoša aminoskābe, tā ir nozīmīgs selēna avots. Selēnmetionīns veic bioantioksidata funkciju, mijiedarbojas ar vitamīniem, fermentiem, bioloģiskajām membrānām bioloģiskajās sistēmās un organismā kopumā. Fermenta sastāvā glutationperoksidāzes neitralizē oksīdus un peroksīdus, pasargā šūnu membrānas no sabrukšanas, veic antihistamīnu iedarbību, stimulē kolagēna, keratīna biosintēzi, piedodot ādai stingrumu un elastību, samazina seborejas izpausmes, aktivizē ādas reģeneratīvos procesus, atjauno epidermas struktūru. Neorganisko selēnu, selēna disulfīdu (Selenium disulfide) lieto galvas ādas matu zonas seborejas ārstēšanai [37], Pēc ASV pieņemta standarta drošs selēna saturs (no intoksikācijas viedokļa) pieauguša cilvēka ikdienā uzņemamajā uzturā ir 50-220 mkg, saskaņā ar Ķīnā veiktajiem pētījumien toksiskas izpausmes netika novērotas, uzņemot diennaktī 750 mkg selēna, bet intoksikācijas simptomi novērojami, ja diennakts devu palielina līdz 5000 mkg/diena [38].Selenomethionine, Se-Met (SEM) - The L-enantiomer of selenium methionine, a natural amino acid containing selenium, is an important source of selenium. Selenomethionine functions as a bioanthoxidate, interacts with vitamins, enzymes, biological membranes in biological systems and the body as a whole. The glutathione peroxidases in the enzyme neutralize oxides and peroxides, protect cell membranes from collapse, perform antihistamines, stimulate collagen, keratin biosynthesis, give skin firmness and elasticity, reduce seborrheic manifestations, activate skin regenerative processes, regenerate skin. Inorganic selenium, selenium disulfide (Selenium disulfide) is used to treat seborrhea of the scalp [37]. According to the US standard, the safe intake of selenium (from the point of view of intoxication) is 50-220 mcg in the daily diet of an adult, according to studies in China were not observed with daily intake of 750 mcg of selenium, but symptoms of intoxication were observed when increasing the daily dose to 5000 mcg / day [38].
Selēnmetionīns ir hidrofila viela, optimālais selēnmetionīna satura efekts krēma sastāvā 0,0005-0,0015 g. Ja tā saturs mazāks par 0,0005 g, tad krēma antioksidatīvā iedarbība samazinājās, bet, ja tā saturs lielāks par 0,0015 g, tad radās grūtības krēma izgatavošanā, izmainījās krēma konsistence, tas noslāņojās, nebija tik viendabīgs, tas apgrūtināja krēma lietošanu.Selenomethionine is a hydrophilic substance, the optimal effect of the content of selenium methionine in the cream is 0.0005-0.0015 g. If its content is less than 0.0005 g, the antioxidant effect of the cream is reduced, but if its content is more than 0.0015 g, it is difficult to make the cream, the consistency of the cream has changed, it is not uniform, it makes it difficult to use.
Skvalāns ((Squalane) - karotinoīdu grupas dabiskas izcelsmes ogļūdeņradis, caurspīdīga eļļa bez krāsas un aromāta. Skvalāns nesatur dubultsaites, tāpēc tas ir ķīmiski stabils un var ' uzglabāties vairāk par 2 gadiem, tas neoksidējas un nekļūst rūgtens. Skvalāns sintezējas tauku dziedzeros, tas ir viens ’ no ādas tauku un ūdenslipīdu mantijas galvenajiem komponentiem. Saskaņā ar dermatokosmetoloģiju skvalans ir augsti kvalitatīvs emolents (mīkstināšanas aģents). Skvalāns ir nekomedogēns, atšķirībā no triglicerīdiem un ādas tauku slāņa taukskābēm [39-10J. Skvalānu uzklājot uz ādas, tas viegli ieziešas, veidojot aizsargājošu plēvi, kas pasargā no mitruma zuduma, uzlabo ādas elpošanu. Pateicoties dabiskajai radniecībai ar ādu, skvalāns viegli izsūcas cauri epidermai, neatstājot nekādu taukainību, vienlaicīgi ādu padara maigu un zīdainu. Skvalāns ir hidrofoba viela, tas aktīvi iesaistās vielmaiņā, steroīdu bioloģiskajā sintēzē, tam piemīt viegls antibakterials efekts, tas palīdz novērst vecuma plankumu rašanos. Optimālais skvalāna satura efekts krēma sastāvā 11,25-18,75 g. Ja tā saturs mazāks par 11,25 g, tad ādas struktūras mīkstināšanas un atjaunošanas efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 18,75 g, tad radās grūtības krēma izgatavošanā, samazinājās kompozīcijas stabilitāte, krēms noslāņojās, tika apgrūtināta tā lietošana.Squalane ((Squalane) - a naturally occurring hydrocarbon of the carotenoid group, a clear colorless and odorless oil. Squalane does not contain double bonds, so it is chemically stable and can be stored for more than 2 years, it does not oxidize and becomes bitter. one of the main components of the skin fat and water lipid mantle. According to dermatocosmetology squalane is a high quality emollient (emollient agent). Squalane is non-comedogenic, unlike triglycerides and fatty acids in the fat layer of the skin [39-10J. Creates a protective film that protects against dehydration, improves respiration of the skin, due to its natural affinity to the skin, squalane is easily absorbed through the epidermis without leaving any grease, and at the same time makes the skin soft and silky. In this synthesis, it has a mild antibacterial effect and helps prevent age spots. Optimal effect of squalane content in the cream 11.25-18.75 g. At a content of less than 11.25 g, the effect of softening and rejuvenating the skin structure was significantly reduced, but at a content of greater than 18.75 g, difficulties were encountered in the preparation of the cream, the stability of the composition was reduced, the cream peeled and application was difficult.
E vitamīns, α-tokoferols (Vitamin E, Alpha-tocopherol) - gaiši dzeltens, caurspīdīgs, viskozs šķidrums ar vāju aromātu. Gaismā oksidējas un kļūst tumšs. Tokoferols ir hidrofoba viela, to satur jauno augu zaļās daļas, augu eļļas, tas ir dabiskais antioksidants, kas piedalās brīvo radikāļu inaktivācijā, pasargā šūnu membrānas no sabrukuma, tajā skaitā, arī ultravioletā starojuma gadījumā, piedalās olbaltumvielu sintēzē, samazina seborejas izpausmes, aktivē ādas reģeneratīvos preocesus [41]. E vitamīna iekļaušana krēma sastāvā ļāva sasniegt daudz ātrāku ādas epidermālās lipīdu barjeras atjaunošanu pacientiem ar metabolisko sindromu. Optimālais α-tokoferola (E vitamīna) satura efekts krēma sastāvā 0,50-1,50 g. Ja tā saturs mazāks par 0,50 g, tad efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 1,50 g, tad izmainījās krēma konsistence, tas kļuva ievērojami šķidrāks, tika apgrūtināta tā lietošana.Vitamin E, α-tocopherol (Vitamin E, Alpha-tocopherol) - pale yellow, translucent viscous liquid with a mild odor. It oxidizes in the light and becomes dark. Tocopherol is a hydrophobic substance, contains green parts of young plants, vegetable oils, is a natural antioxidant that participates in free radical inactivation, protects cell membranes from collapse, including in the case of ultraviolet radiation, participates in the synthesis of proteins, regenerative pre-processes [41]. The incorporation of vitamin E into the cream allowed for a much faster restoration of the skin's epidermal lipid barrier in patients with metabolic syndrome. Optimal effect of α-tocopherol (vitamin E) content in the cream 0,50-1,50 g. If its content was less than 0.50 g, the effect was greatly reduced, but if its content was greater than 1.50 g, the consistency of the cream changed, it became significantly thinner and its use was difficult.
Metil—4-hidroksibenzoāts (Methyl paraben), СНз(СбЩ(ОН)СОО) - baltas krāsas vai krēmkrāsas kristālisks pulveris, kas slikti šķīst ūdenī. Tas šķīst siltā ' ūdenī, metanolā, propilēnglikolā. To raksturo plašs antibakteriālās un pretsēnīšu iedarbības spektrs, · tas dabiskā veidā sintezējas dažos augos, piemēram, mellenēs. To lieto pret pelējuma un gramnegatīvām baktērijām [42]. Cilvēka organismā viegli un pilnīgi uzsūcas caur ādu vai caur kuņģa-zamu traktu, sadalās vienkāršākās vielās un ātri tiek izvadīts ar urīnu, neuzkrājoties organismā. To izmanto par stabilizatoru un/vai prolongatoru, efektīvs ļoti zemās koncentrācijas, tīrā veidā un 0,25 %-5 % spirta šķīduma veidā. Optimālais metil-4-hidroksibenzoāta satura efekts krēma sastāvā 0,05-0,15 g. Ja tā saturs mazāks par 0,05 g, tad stabilizatora efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 0,15 g, tad izmainījās krēma konsistence, bija manāmi neizšķīdušie ieslēgumi, tika apgrūtināta krēma lietošana.Methyl 4-hydroxybenzoate (Methyl paraben), СНз (СбЩ (ОН) СОО) - white or cream crystalline powder, poorly soluble in water. It is soluble in warm water, methanol, propylene glycol. It is characterized by a broad spectrum of antibacterial and antifungal activity, and is naturally synthesized in some plants, such as blueberries. It is used against mold and gram-negative bacteria [42]. It is easily and completely absorbed into the human body through the skin or through the gastrointestinal tract, degrades into simpler substances and is rapidly excreted in the urine without accumulation in the body. It is used as a stabilizer and / or extender, effective in very low concentrations, in pure form and in the form of a 0.25% to 5% alcoholic solution. Optimal effect of the content of methyl 4-hydroxybenzoate in the cream 0.05-0.15 g. If its content is less than 0.05 g, the effect of the stabilizer is significantly reduced, but if its content is greater than 0.15 g, the consistency of the cream is changed, the insolubles are noticeable and the use of the cream is difficult.
Glicerīna monostearāts 60 (Glycery Stearate) - baltas krāsas pulveris, kas iegūts no dabiskās stearinskābes un glicerīna, ar perlamutra efektu (atstaro gaismu), ir vaskveidīgs, ciets emolents, emulgators un biezinātājs, to pievieno samaisīšanas fāzes stabilizācijas procesā. Tiek lietots kā stabilizējošs un strukturizējošs komponents, lai novērstu sastāva (kompozīcijas) hidrofobās un hidrofilās fāzes atdalīšanu, nosēdumu . atdalīšanu· [43]. Ja tā saturs mazāks par 2,52 g, tad biezinātāja efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 4,20 g, tad izmainījās krēma konsistence, krēms kļuva ļoti biezs, tika apgrūtināta krēma lietošana.Glyceryl Monostearate 60 (Glycery Stearate) - A white powder derived from natural stearic acid and glycerin with a pearly-light effect (reflecting light), is a waxy, solid emulsion, emulsifier and thickener, added during the blending phase of stabilization. Used as a stabilizing and structuring component to prevent separation of the hydrophobic and hydrophilic phases of the composition (composition). separation [43]. If its content is less than 2.52 g, the effect of the thickener is significantly reduced, but if its content is greater than 4.20 g, the consistency of the cream has changed, the cream has become very thick and the use of the cream has been difficult.
Cetilspirts (Cetyl alcohol, l-hexadecanol), СЕ^СНУмСНгОН, vienatoma taukains spirts, cieta baltas krāsas viela, tauku bāzes sastāvā tiek lietots par emulgatoru un/vai saduļkotāju (opacifier), kas uzlabo konsistenci, paaugstina ūdenseļļas maisījuma stabilitāti [44]. Lietošanai rekomendējamie grami: 3,78-6,29 g. Ja tā saturs mazāks par 3,78 g, tad emulgatora efekts ievērojami samazinājās, krēms noslāņojās, bet, ja tā saturs lielāks par 6,29 g, tad mainījās krēma konsistence, krēms kļuva pārāk šķidrs, tika apgrūtināta krēma lietošana.Cetyl alcohol (Cetyl alcohol, l-hexadecanol), carbon monoxide, a monohydric fatty alcohol, a white solid, is used in the fat base as an emulsifier and / or opacifier, which improves consistency, increases the stability of the water-oil mixture [44]. Recommended grams for use: 3.78-6.29 g. If its content is less than 3.78 g, the effect of the emulsifier is significantly reduced, the cream is peeled off, but if its content is higher than 6.29 g, the consistency of the cream changes, the cream becomes too liquid and the use of the cream is difficult.
Vidēji garo ķēžu triglicerīdi (Triglycerides medium-chain) — eļļains šķīdums, kas iegūts no kokoseļļas, nesšķīstošs ūdenī, sajaucams ar eļļām [45]. Uzlabo krēma izvietojuma vienmērību uz ādas, izšķīdina lipofilos savienojumus. Lietošanai rekomendējamie grami: 4,72-7,87 g. Ja tā saturs mazāks par 4,72 g, tad stabilizatora efekts ievērojami samazinājās, krēms noslāņojās, bet, ja tā saturs lielāks par 7,87 g, tad mainījās krēma konsistence, krēms kļuva pārāk šķidrs, tas apgrūtināja krēma lietošanu.Triglycerides medium-chain - an oily solution of coconut oil, water insoluble, miscible with oils [45]. Improves the uniformity of the cream's application to the skin, dissolves lipophilic compounds. Recommended grams for use: 4.72-7.87 g. If its content is less than 4.72 g, the effect of the stabilizer is significantly reduced, the cream is peeled off, but if its content is more than 7.87 g, the consistency of the cream is changed, the cream becomes too liquid, which makes it difficult to use.
Baltais vazelīns (Vaselinum) - cietu un mīkstu augstmolekulāru ogļūdeņražu maisījums, kas iegūts, samaisot balto cerezīnu un parafīnu ar parfimērijas eļļu [46]. Vazelīnu lieto kā biezinātāju ādas krēmu un ziežu sastāvā. To lietojot ārēji, vazelīns sekmē ādas ūdens—lipīdu aizsargmantijas atjaunošanos, novērš šķidruma zudumu ādas šūnās, novērš ādas lobīšanos un plaisas. Vazelīns paredzēts sejas un roku ādas mīkstināšanai, tajā skaitā, ārējās vides negatīvo faktoru ietekmes izraisītajos gadījumos (saule, vējš, temperatūras izmaiņas). Ja tā saturs mazāks par 16,05 g, tad biezinātāja efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 26,74 g, tad mainījās krēma konsistence, krēms kļuva pārāk biezs, tas apgrūtināja krēma lietošanu.White Vaseline (Vaselinum) - A blend of hard and soft high molecular weight hydrocarbons obtained by mixing white ceresin and paraffin with perfume oil [46]. Vaseline is used as a thickener in skin creams and ointments. When applied externally, petroleum jelly promotes the regeneration of the skin's water-lipid protective mantle, prevents fluid loss in skin cells, prevents peeling and cracks. Vaseline is intended to soften the skin of the face and hands, including in cases caused by external factors (sun, wind, temperature changes). If its content was less than 16.05 g, the effect of the thickener was significantly reduced, but if its content was greater than 26.74 g, the consistency of the cream changed, the cream became too thick, which made it difficult to use the cream.
Makrogols-20-glicerīna monostearāts (Macrogot), struktūrformula НО-(СНг-СНг-О)п-Н, balts pulveris, veido ūdeņraža saites ar ūdens molekulām, to lieto medicīnā un kosmētikā kā savienojošo komponentu, izgatavojot bāzi ziedēm, to lieto arī kā stabilizējošo un strukturizējošo komponentu, kas padara sastāvu vienmērīgu [47]. Makrogola augstā hidrofilā pakāpe ļauj visefektīvāk veikt kompozīcijas homogenizāciju daudzumā 4,40-7,34 g, emulģējot jaunā krēma hidrofobos komponentus. Ja tā saturs mazāks par 4,40 g, tad biezinātāja efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 7,34 g, tad mainījās krēma konsistence, krēms kļuva pārāk biezs, tas apgrūtināja krēma lietošanu.Macrogol-20-glycerol monostearate (Macrogot), structural formula НО- (СНг-СНг-О) п -Н, a white powder, forms hydrogen bonds with water molecules, is used in medicine and cosmetics as a bonding ingredient, it is also used in ointment base. as a stabilizing and structuring component which makes the composition uniform [47]. The high hydrophilic degree of macrogol allows the most effective homogenisation of the composition in the amount of 4.40-7.34 g by emulsifying the hydrophobic components of the new cream. If its content is less than 4.40 g, the effect of the thickener is significantly reduced, but if its content is greater than 7.34 g, the consistency of the cream has changed, the cream has become too thick, which makes it difficult to use.
1,2-propāndioIs (1,2-propylenglycot), СНзСН(ОН)СН2ОН, organiska viela, bezkrāsains, viskozs hidroskopisks šķidrums, bez aromāta, mitrumu uzturēšanas, mīkstināšanas un disperģēšanas aģents, labs šķīdinātājs [48]. Ar to pilnīgi sajaucas vairums mazmolekulāru organisku savienojumu, saturošu skābekli un slāpekli. Ja tā saturs mazāks par 6,29 g, tad biezinātāja efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 10,49 g, tad mainījās krēma konsistence, tas kļuva pārāk biezs un tika apgrūtināta krēma lietošana.1,2-Propanediol (1,2-propylenglycot), СНзСН (ОН) СН2ОН, organic substance, colorless viscous hydroscopic liquid, odorless, humectant, softening and dispersing agent, good solvent [48]. Most low molecular weight organic compounds containing oxygen and nitrogen are completely mixed with it. If its content is less than 6.29 g, the effect of the thickener is significantly reduced, but if its content is greater than 10.49 g, the consistency of the cream is changed, it becomes too thick and the use of the cream is difficult.
Ūdens (Aqua) bāzes sastāvā ietilpst kā emulsijas „ūdens eļļā” daļa (kur ūdens - emulsijas hidrofilā daļa, eļļa un skvalēns - hidrofobā daļa). Lietošanai rekomendējamais daudzums: līdz 100 g. Ja tā saturs mazāks par 33,0 g, tad biezinātāja efekts ievērojami samazinājās, bet, ja tā saturs lielāks par 34,6 g, tad mainījās krēma konsistence, tas kļuva pārāk biezs, tika apgrūtināta krēma lietošana.The water (Aqua) base contains as part of the "water in oil" emulsion (where water is the hydrophilic part of the emulsion, oil and squalene is the hydrophobic part). Recommended use: up to 100 g. If its content is less than 33.0 g, the effect of the thickener is significantly reduced, but if its content is greater than 34.6 g, the consistency of the cream has changed, it has become too thick and the use of the cream has been difficult.
Jaunais krēma sastāvs tika sekmīgi lietots, iegūstot dozētu formu tūbās pa 65,0 g (pa 30,0 g). Visi jaunā krēma sastāva komponenti, kā atsevišķi preparāti, atļauti lietošanai dermatoloģijā izgudrojumā minēto attiecību robežās. Jaunā krēma sastāvs un izgatavošanas tehnoloģija atbilst produktu drošības novērtējuma standarta kritērijiem saskaņā ar Eiropas Komisijas prasībām (Parlamenta un Padomes regula (EK) Nr.1223/2009 (2009. gada 30. novembris) par kosmētikas līdzekļiem, 11. pants).The new cream formulation was successfully used to obtain a dosage form of 65.0 g (30.0 g) in tubes. All components of the new cream composition, as separate preparations, are authorized for use in dermatology within the scope of the invention. The composition and manufacturing technology of the new cream meet the standard criteria for product safety assessment as required by the European Commission (Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, Article 11).
I - П. Krēma sastava piemeriI - П. An example of a cream composition
Krēma iegūšanas paņēmiensThe method of obtaining the cream
Jaunā krēma sastāva izgatavošanas sarežģītība saistīta ar to, ka skvalāns, glicerīns, triglicerīdi, vazelīns un α-tokoferols ir hidrofobas vielas, bet selēnmetionīns, makrogols, propāndiols - hidrofilas vielas.The complexity of the new cream formulation is due to the fact that squalane, glycerol, triglycerides, petroleum jelly and α-tocopherol are hydrophobic substances, while selenomethionine, macrogol, propanediol are hydrophilic substances.
Pirmā krēma sastāva iegūšanas paņēmiensMethod of obtaining the first cream composition
1. Krēma hidrofobās daļas pagatavošana.1. Preparation of the hydrophobic part of the cream.
Krēma pagatavošanas traukā ūdens vannā 65-70 °C temperatūrā izkausē 2,52-4,20 g glicerīna monostearāta 60 un 3,78-6,29 g cetilspirta, pievieno un izkausē 16,05-26,74 g vazelīna, pievieno 11,25-18,75 g skvalāna un 4,72-7,87 g vidēji garo ķēžu triglicerīdus, maisa līdz viendabīgumam. Sakausējuma temperatūrai jābūt 60 °C.Melt 2.52-4.20 g of glycerol monostearate 60 and 3.78-6.29 g of cetyl alcohol in a water-bath in a water bath at 65-70 ° C, add and melt 16.05-26.74 g of petroleum jelly, add 11, 25-18,75 g squalane and 4,72-7,87 g medium chain triglycerides, stir until homogeneous. The temperature of the alloy should be 60 ° C.
2. Krēma hidrofilās daļas pagatavošana.2. Preparation of the hydrophilic part of the cream.
Stikla vārglāzē 6,29-10,49 g 1,2-propāndiola 45-50 °C temperatūrā izšķīdina 0,05-0,15 g metil-4-hidroksibenzoāta, pievieno daļu no atlikušā attīrīta ūdens, samaisa, pievieno 4,40-7,34 g makrogola-20-glicerīna monostearāta, izšķīdina, sildot līdz 60 °C temperatūrai.Dissolve 0.05-0.15 g of methyl 4-hydroxybenzoate in a glass beaker 6.29-10.49 g of 1,2-propanediol at 45-50 ° C, add some of the residual purified water, mix, add 4,40- 7.34 g of macrogol-20-glycerol monostearate are dissolved by heating to 60 ° C.
3. Krēma . pagatavošanas traukā pie hidrofobās daļas pievieno hidrofilo daļu, maisa krēma maisīšanas iekārtā 15-20 minūtes, kamēr masa atdziest līdz 30-35 °C temperatūrai.3. Cream. Add the hydrophilic part to the hydrophobic part in the preparation container, stir in the cream mixer for 15-20 minutes until the mass has cooled to 30-35 ° C.
4. Krēma masai pievieno 0,50-1,50 g α-tokoferola acetāta un 0,0005-0,0015 g selēn-L-metionīna, kas izšķīdināts daļā no atlikušā attīrītā ūdens. Maisa krēma maisīšanas iekārtā 10 minūtes līdz viendabīgas masas iegūšanai.4. To the weight of the cream add 0,50 to 1,50 g of α-tocopherol acetate and 0,0005 to 0,0015 g of selenium L-methionine dissolved in some of the purified water. Stir the cream in the mixer for 10 minutes until homogenous.
Otrā sastāva iegūšanas paņēmiens - analoģisks pirmajam. Iegūto krēmu fasē alumīnija tūbās pa 65,0 g (pa 30,0 g).The method of obtaining the second composition is analogous to the first. The resulting cream is packaged in aluminum tubes of 65.0 g (30.0 g each).
Krēma sastāvs ir homogēna masa baltā krāsā vai baltā krāsā ar dzeltenīgu nokrāsu, vāji izteiktu un patīkamu aromātu, atbilstošu lietotajai tauku bāzei.The composition of the cream is a homogeneous mass of white or white with a yellowish tinge, with a slight and pleasant aroma, corresponding to the fat base used.
Krēms paredzēts sejas ādas, kakla un dekoltē zonas epidermālās lipīdu barjeras atjaunošanai pacientiem ar metabolisko sindromu. Krēmam piemīt komponentu biosadenba, tas viegli iesūcas ādā, to pārklājot ar plānu, elastīgu slāni, krēma pH 4,0-5,0. Krēmam piemīt ādu nomierinoša iedarbība, tas mazina niezi un iekaisumu, to ilgstoši lietojot, tas neizraisa kairinājumus un blaknes.The cream is intended for restoring the epidermal lipid barrier of the facial skin, neck and décolleté in patients with metabolic syndrome. The cream has the biosadenba component and is easily absorbed into the skin by applying a thin, elastic layer to the cream pH 4.0-5.0. The cream has a soothing effect on the skin, it relieves itching and inflammation, it does not cause irritations and side effects after prolonged use.
Lai novērtētu krēma īpašības, saistībā ar ādas epidermālās lipīdu barjeras profilaksi un/vai atjaunošanu, izmantojot „LIPEX” (Rīga) dermatoloģijas klīnikas un estētiskās medicīnas bāzi, tika veikts prospektīvs klīnisks pētījums, kura ietvaros informatīvas, brīvprātīgas piekrišanas apstākļos tika aicināti vīrieši un sievietes ar metabolisko sindromu vecumā 39-55 gadi. Rezultātā tika atlasītas 2 vienveidīgas pacientu grupas ar metabolisko sindromu, kuri, nesmēķē, neapmeklē solāriju, ar vidēju insolācijas pakāpi (vidēja saules ekspozīcija, visu sezonu pavada Vidus- un Ziemeļeiropas apstākļos). Pirmās grupas (1. grupa, n=12) un otrās grupas (2. grupa, n=15) sastāvā iekļauti pacienti, kuriem diagnosticēts metaboliskais sindroms. Metaboliskā sindroma diagnoze tika noteikta, pamatojoties uz izmaiņu kompleksu, saskaņā ar Starptautisko slimību klasifikatoru (10. izdevums) [1] un ASV Nacionālā veselības aizsardzības institūta speciālistu veikto analīzi: metaboliskais sindroms tika noteikts pēc trijiem vai vairākiem simptomiem:A prospective clinical study was conducted to evaluate the properties of the cream in the prevention and / or restoration of the epidermal lipid barrier of the skin using the LIPEX (Riga) Dermatology Clinic and Aesthetic Medicine Base. metabolic syndrome aged 39-55 years. As a result, 2 homogeneous patient groups with metabolic syndrome who do not smoke, do not attend a solarium, and have a moderate degree of insolation (moderate sun exposure, spend all season in Central and Northern Europe). The first group (group 1, n = 12) and the second group (group 2, n = 15) included patients diagnosed with metabolic syndrome. The diagnosis of the metabolic syndrome was based on a set of changes, according to the International Classification of Diseases (10th Edition) [1] and analysis by specialists at the US National Institute of Health: Metabolic syndrome was defined by three or more symptoms:
• aptaukošanās abdominālais tips - vidukļa apkārtmēra rādītājs lielāks par 89 cm sievietēm un lielāks par 102 cm vīriešiem, • glikozes līmenis tukšā dūšā — lielāks par 6,1 mmol/1, • trigliceridu līmenis - iielāks par 1,69 mmol·!, • zema blīvuma lipoproteīnu līmeņa pazemināšanās: sievietēm - mazāks par• Abdominal type of obesity - waist circumference greater than 89 cm in women and greater than 102 cm in men • fasting glucose level greater than 6.1 mmol / l • triglyceride level greater than 1.69 mmol ·! • low Decreased density of lipoproteins: in women less than
1,29 mmol/1; vīriešiem - mazāks par 1,04 mmc^l/1, • arteriālā asinsspiediena līmenis 135/85 mmHg.1.29 mmol / l; men - less than 1.04 mmc ^ l / 1, • arterial blood pressure level 135/85 mmHg.
Pētījuma protokols, vienošanās un dalības protokols, dalības 'anketa atbilst Pasaules Medicīnas asociācijas (PMA) Helsinku deklarācijas ētiskajiem un humānisma principiem medicīnā, kā arī apstiprināti Rīgas Stradiņa universitātes Ētikas komisijā. Interešu konflikts nepastāv.The study protocol, agreement and membership protocol, the membership questionnaire are in accordance with the World Medical Association's (PMA) Helsinki Declaration of Ethical and Humanistic Principles in Medicine, and approved by the Riga Stradins University Ethics Commission. There is no conflict of interest.
1. grupas pacientiem (n=12), pēc iepriekšējas k^l^īnis^f^Ē^s izmeklēšrnras, krēms tika nozīmēts ilgstoši (2 mēnešus, aktīvas UV insolācijas laikā, maija un jūnija mēnešos). Krēmu uzklāja plānā kārtiņā, 2 reizes dienā (rītā un vakarā) uz tīras sejas ādas, kakla un dekoltē zonas. 2. grupas pacienti krēmu nelietoja. Abās grupās klīniskos pētījumus atkārtoja pēc 14, 30 un 60 dienām, sākot no krēma lietošanas sākuma.In Group 1 patients (n = 12), after previous examination, the cream was administered over a long period (2 months, during active UV insolation, in May and June). The cream was applied in a thin layer, twice a day (morning and evening), on clean face, neck and décolleté areas. Group 2 patients did not use the cream. In both groups, clinical trials were repeated at 14, 30 and 60 days after the start of the cream application.
Klīniskie pētījumi ietvēra antropometriskos datus (ķermeņa masas indekss, vidukļa apkārtmērs, arteriālais asinsspiediens), asins analīzi (glikoze, lipoproteīni). Lai novērtētu ādas epidermālo lipīdu barjeru, veica siaskopiju un dermatoskopiju (siaskops MoleVievv SIAscope V Handset, Astron, Lielbritānija un dermatoskops HEINE alpha + Heine Optotechnic, Vācija). Ādas reljefa un morfoloģijas stāvoli (turgors, mikroreljefs un papilomu esamība) novērtēja ar dermatoskopijas starpniecību. Pigmentāciju un lobīšanos novērtēja, izmantojot siaskopiju. pH-metrijas mērījumus veica ar pH-metrijas sensora palīdzību. Transepidermālā ūdens zuduma mērījumus veica ar sensora Tewameter® TM 300, Courage + Khazaka electronic GmbH, Vācija, (tevametrija) palīdzību. Ar šiem sensoriem iegūtu pētījuma rezultātu aprēķinu un saglabāšanu veica, izmantojot programmnodrošinājumu datu bāzē SPSS20,0 (Microsoft:, ASV). Rezultātus reģistrēja skaitliskās vērtībās. Korneometrijas rādītāju normālo vērtību robežas bija no 40 un augstākas, tevametrijas - zemākas par 12, pH-metrijas - robežās no 5,5 līdz 5,8. Katru pazīmi novērtēja pēc skalas no 0 līdz 3 ballēm: 0 - pazīme neeksistē, 2 - pazīme izteikta mēreni, 3 - pazīme izteikta spēcīgi.Clinical trials included anthropometric data (body mass index, waist circumference, arterial blood pressure), blood tests (glucose, lipoproteins). Siascopy and dermatoscopy (Sole MoleVievv SIAscope V Handset, Astron, UK and HEINE alpha + Heine Optotechnic, Germany) were performed to evaluate the epidermal lipid barrier of the skin. Dermatoscopy assessed skin relief and morphology (turgor, microrelief, and presence of papillomas). Pigmentation and flaking were evaluated using siascopy. The pH-metry was measured with the aid of a pH-meter. Transepidermal water loss was measured using a Tewameter® TM 300 (Courage + Khazaka electronic GmbH, Germany) (Toulameter) sensor. Study results obtained with these sensors were calculated and saved using software in database SPSS20.0 (Microsoft :, USA). The results were recorded in numerical values. Normal values for cornealometry ranged from 40 and higher, to those below 12, and to pH-metric values between 5.5 and 5.8. Each trait was rated on a scale of 0 to 3: 0 - no trait, 2 - moderate, 3 - strong.
Vērtēja strukturālo izmaiņu datus un veica ādas imunitātes vērtējumu: veica histoloģiskos pētījumus, izmantojot gaismas mikroskopiju. Gaismas mikroskopijas palielinājums - 400 reizes, ar imūnhistoķīmijas metožu palīdzību, lietojot CDla, CD31, CD34, CD3, CD8.Structural change data were evaluated and skin immunity was assessed: histological studies were performed using light microscopy. Light microscopy magnification - 400-fold by immunohistochemistry using CDla, CD31, CD34, CD3, CD8.
2. tabula - ar metabolisko sindromu sirgstošu abu pacientu grupu klīnisko pētījumu rezultāti.Table 2 - Results of clinical trials in both patient groups with metabolic syndrome.
2. tabulaTable 2
Veicot pētījumu, vairumam pacientu no abām grupām, noteica sūdzības par ādas sausumu un pastiprinātu lobīšanos.In the study, the majority of patients in both groups had complaints of dry skin and increased exfoliation.
Klīnisko pētījumu rezultātā 1. grupas pacientiem (12), kuri lietoja jaumo krēmu 2 mēnešus, tika iegūti šādi rādītāji: 1) ādas mitrums bija 27, 2±1, t.i., augstāks, salīdzinot ar 2. grupas pacientiem (15) - 19,1±1,2; 2) lobīšanās - 1,8 bija 1. grupas pacientiem un 2,6 - 2. grupas pacientiem, t.i., lobīšanās bija vairāk izteikta 2. grupas pacientiem; 3) pigmentācija - 1,2 bija 1. grupas pacientiem un 2,8 - 2. grupas pacientiem, t.i,, pigmentācija bija vairāk izteikta 2. grupas pacientiem; 4) ādas reljefs - 1,6 bija 1. grupas pacientiem un 2,8 bija 2. grupas pacientiem, t.i., papilomu esamība un ādas elastoze bija vairāk izteikta 2. grupas pacientiem.In clinical studies, patients in group 1 (12) who had been using the cream for 2 months had the following parameters: 1) skin moisture was 27, 2 ± 1, ie higher compared to group 2 (15) - 19, 1 ± 1.2; 2) Exfoliation - 1.8 was in Group 1 patients and 2.6 was in Group 2 patients, i.e. exfoliation was more pronounced in Group 2 patients; 3) Pigmentation - 1.2 was in Group 1 patients and 2.8 in Group 2 patients, i.e., pigmentation was more pronounced in Group 2 patients; 4) Skin relief - 1.6 was in group 1 patients and 2.8 was in group 2 patients, i.e., the presence of papillomas and skin elastosis were more pronounced in group 2 patients.
Tādējādi 1. grupas pacientiem, kuri lietoja jauno . krēmu 2 mēnešu laikā, konstatēja ādas barjerfunkcijas stāvokļa, ādas reljefa un elastības atjaunošanos.Thus, in Group 1 patients who received the new. cream within 2 months, restoration of skin barrier function, skin relief and elasticity.
Saskaņā ar datiem, kas iegūti pētot ādas imunitāti, ādas imunitātes šūnu (Langerhansa šūnas) aktivitāte 2. grupas pacientiem bija pazemināta. Turklāt 2. grupas pacientu ādā bija novērojama limfocitārā infiltrācija un Birbeka granulu uzkrāšanās (liecina pa.r iekaisuma procesu). 1. grupas pacientu ādā jaunā krēma lietošanas fonā pieauga imūnkompetento Langerhansa šūnu daudzums, par divām reizēm samazinājās Birbeka granulu skaits, kas liecināja par vietējās ādas imunitātes uzlabošanos.Skin immunity cells (Langerhans cells) showed reduced activity in Group 2 patients, according to data from skin immunity studies. In addition, lymphocytic infiltration and accumulation of Birbeck's granules (indicative of an inflammatory process) were observed in the skin of patients in group 2. In the skin of patients in Group 1, the amount of immunocompetent Langerhans cells increased in the background of the new cream, with a doubling of Birbeck's granules, indicating an improvement in local skin immunity.
Veiktie pētījumi pierādīja, ka jaunajam krēma sastāvam piemīt kosmētiskās un ārstniecisld-profilaktiskās īpašības, tas atjauno ādas epidermālo lipīdu barjeru un ādas barjcrfunkciju pacientiem ar metabolisko sindromu: uzlabo ādas turgoru un mitruma stāvokli, atjauno elastību un ādas gludo reljefu, samazina pigmentācijas izpausmes, iekaisuma papilomas.Studies have shown that the new cream composition has cosmetic and therapeutic properties, restores the skin's epidermal lipid barrier and skin barrier function in patients with metabolic syndrome: improves skin turgor and moisture, restores elasticity and smooth skin relief, reduces the appearance of pigmentation, .
Izgudrojuma sarežģītība saistīta ar to, ka nebija zināmi jaunā sastāva komponenti un to savstarpējā attiecība, līdz ar kuriem jaunais sastāvs varētu veikt efektīvu atjaunojošu iedarbību uz ādas epidermālo lipīdu barjera. Krēma izstrādāšanu papildus sarežģīja apstāklis, ka jaunā sastāva komponenti bija gan hidrofilas (selēnmetionīns), gan hidrofobas (E vitamīns, skvalāns) vielas. Nebija zināmi apstākļi, kuros jaunā sastāva hidrofilie un hidrofobie komponenti varētu būt savienojami vienā krēmā, kuram piemīt augsta taukainības pakāpe. . Eksperimentāli iegūtie komponenti, to savstarpējā attiecība un jaunā krēma sastāva iegūšanas tehnoloģiskie apstākļi ļāva izgatavot stabilu homogēnu jaunā krēma sastāvu, kas saglabā savu efektivitāti un stabilu konsistenci istabas temperatūrā 6-8 mēnešu laikā.The complexity of the invention is due to the lack of knowledge of the components of the new composition and their relationship, which would allow the new composition to exert an effective restorative effect on the epidermal lipid barrier of the skin. The development of the cream was further complicated by the fact that the components of the new composition were both hydrophilic (selenomethionine) and hydrophobic (vitamin E, squalane) substances. The conditions under which the hydrophilic and hydrophobic components of the new formulation could be compatible in a single cream with a high degree of grease were not known. . Experimentally obtained components, their mutual ratio and technological conditions for obtaining the new cream composition allowed to produce a stable homogeneous composition of the new cream, which retains its effectiveness and stable consistency at room temperature for 6-8 months.
Jaunā krēma sastāvs ir ūdens un tauku, taukveidīgu un citu vielu maisījums. Augstais lauku sastāva un taukveidīgu vielu procentuālais sastāvs svarīgs, lai sasniegtu ādas epidermālās lipīdu barjeras un ūdens-lipīdu mantijas atjaunošanas efektu. Pastāv tehnoloģiskas grūtības, savienojot tādu skaitu taukvielu, bez gatavā produkta noslāņošanās riska. Šāda tipa krēmiem ir svarīgi lietot īpašus emulgatorus, kuru iekļaušana pieteiktajā attiecībā ļauj iegūt jaunā krēma sastāva vienmērīgu krēmveida konsistenci, kas saglabā stabilitāti uzglabāšanas procesā un gatavās zāļu formas ērtu ekstrūziju no iepakojuma (tūbas), kas ļoti svarīgi pacienta lietošanas ērtībai. Pieteiktā jaunā krēma sastāva atšķirīgās īpatnības ir tajā apstāklī, ka par emulgatoriem tiek izmantotas vairākas vielas, katrai no tām piemīt struktūrveidojošas un emulģējošas īpašības. Vienlaikus lietotie emulgatori, kurus ievada krēma sastāvā stingri noteiktā secībā, saskaņā ar pieteiktā izgudrojuma tehnoloģiju nodrošina efektīvu un stabilu jaunā krēma kompleksā sastāva saglabāšanu. Hidrofilo komponentu (ūdens, selēnmetionīns, glicerīns) noteikta savstarpējā attiecība un šķīdinātāju (cetilspirts, glicerīns) noteikta savstarpējā attiecība ļauj saglabāt hidrofilo (selēnmetionīns) un hidrofobo (tokoferols, skvalāns, triglicerīdi) vielu aktivitāti, kuras iekļautas krēma kompozīcijas sastāvā.The composition of the new cream is a mixture of water and fat, greasy and other substances. The high percentage of field and greasy substances is important to achieve the effect of restoring the skin's epidermal lipid barrier and water-lipid mantle. There is a technological difficulty in blending such a number of fats without the risk of delamination of the finished product. For these types of creams, it is important to use special emulsifiers, the inclusion of which in the claimed ratio allows a uniform creamy consistency of the new cream composition, which maintains stability during storage and convenient extrusion of the finished dosage form from the package. The difference in composition of the claimed new cream is due to the fact that several substances are used as emulsifiers, each of which has structuring and emulsifying properties. Concomitantly used emulsifiers which are introduced into the cream in a strictly sequential order, according to the technology of the claimed invention, provide an effective and stable preservation of the complex composition of the new cream. A certain ratio of hydrophilic components (water, selenomethionine, glycerol) and a certain ratio of solvents (cetyl alcohol, glycerol) allows the activity of hydrophilic (selenomethionine) and hydrophobic (tocopherol, squalane, triglycerides) substances contained in the cream composition to be maintained.
Jaunā krēma sastāvs netika konstatēts zinātniski tehniskās un patentu informācijas avotos. Veiktie eksperimentālie un klīniskie pētījumi liecina, par atbilstību kritērijam „izgudrojuma līmenis”The composition of the new cream was not found in scientific and patent sources. Experimental and clinical studies carried out indicate compliance with the criterion of "inventive step"
RŪPNIECISKĀ IZMANTOŠANAINDUSTRIAL USE
Izstrādātas 2 rūpnieciskās krēma formas - 65,0 g (pa 30,0 g) gaismas necaurlaidīgās alumīnija tūbās. Abu jaunā krēma sastāva formu stabilitāte un tehnoloģiskās īpašības saglabājas 6 mēnešu laikā istabas temperatūrā.Developed in 2 industrial cream shapes - 65.0 g (30.0 g each) in light-proof aluminum tubes. The stability and technological properties of both formulations of the new cream are maintained for 6 months at room temperature.
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Claims (2)
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LVP-15-90A LV15082B (en) | 2015-08-24 | 2015-08-24 | Cream for restoring epidermal lipid barrier of the facial skin, neck and decollette area in metabolic syndrome patients |
PCT/LV2015/000006 WO2017034384A1 (en) | 2015-08-24 | 2015-08-25 | Epidermal lipid barrier restoring cream for facial skin, neck and decollete area for metabolic syndrome patients |
EP15902371.2A EP3439616A4 (en) | 2015-08-24 | 2015-08-25 | Epidermal lipid barrier restoring cream for facial skin, neck and decollete area for metabolic syndrome patients |
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LVP-15-90A LV15082B (en) | 2015-08-24 | 2015-08-24 | Cream for restoring epidermal lipid barrier of the facial skin, neck and decollette area in metabolic syndrome patients |
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LV15082A LV15082A (en) | 2015-12-20 |
LV15082B true LV15082B (en) | 2016-04-20 |
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LVP-15-90A LV15082B (en) | 2015-08-24 | 2015-08-24 | Cream for restoring epidermal lipid barrier of the facial skin, neck and decollette area in metabolic syndrome patients |
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WO2017214497A1 (en) | 2016-06-10 | 2017-12-14 | Clarity Cosmetics Inc. | Non-comedogenic hair and scalp care formulations and method for use |
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EP0336000B1 (en) * | 1988-04-08 | 1993-03-17 | Stada Arzneimittel Ag | Ambiphilic cream |
US6630442B1 (en) * | 1997-01-10 | 2003-10-07 | Theodore Hersh | Reparatives for chemosurgery and laser (thermal) therapy |
WO2001017484A2 (en) * | 1999-09-07 | 2001-03-15 | D.T.R. Dermal Therapy Research Inc. | Topical urea composition |
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EP3439616A1 (en) | 2019-02-13 |
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